First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01191372
First received: August 26, 2010
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to examine the safety, tolerability and the way the body handles various single and multiple doses of ARC19499 in patients with hemophilia.


Condition Intervention Phase
Hemophilia
Drug: placebo control
Drug: ARC19499
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Pharmacokinetics (PK) of ARC19499 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The PK profile of ARC19499 administered by single and multiple subcutaneous injections will be characterized. The bioavailability of subcutaneously injected ARC19499 relative to that of intravenously infused ARC19499 will be determined.


Secondary Outcome Measures:
  • Coagulation system pharmacodynamic (PD) effects of ARC19499. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The PD profile of ARC19499 with respect to the kinetics of thrombin generation and clot formation will be characterized.


Enrollment: 17
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: saline for injection Drug: placebo control
sterile saline for injection
Experimental: ARC19499 Low Dose Drug: ARC19499
Anti-tissue factor pathway inhibitor (TFPI) aptamer
Experimental: ARC19499 Mid Dose Drug: ARC19499
Anti-tissue factor pathway inhibitor (TFPI) aptamer
Experimental: ARC19499 High Dose Drug: ARC19499
Anti-tissue factor pathway inhibitor (TFPI) aptamer

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult male patients ≥18 to ≤75 years of age.

  • Hemophilia of any type or severity.
  • Patients who are negative for hepatitis B surface antigen (HBsAg), and human immunodeficiency virus (HIV) I and II antibody tests at screening.
  • Male patients who, with their partners, are willing to use 2 effective, methods of contraception (i.e., for both self and partner) throughout the study and for at least 3 months after discontinuation of study drug treatment.
  • All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document.

Exclusion Criteria:

  • Female patients;
  • If on a prophylactic coagulation factor concentrate regimen, inability or unwillingness to discontinue prophylaxis during participation in this study.
  • Existence of other co-existing bleeding disorder (e.g., von Willebrand Disease).
  • Medical history of venous or arterial thromboembolism.
  • Scheduled for elective surgical procedure during the conduct of this study.
  • Use of an investigational drug within 30 days of study entry.
  • Transaminase values > 3 x upper limit of normal (ULN) at time of screening.
  • Haemoglobin <12.0 g/dL.
  • Participants who, in the opinion of the Investigator, have a significant infection or known inflammatory process on screening.
  • Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
  • Any medical condition the investigator believes would place the patient at increased risk as a result of participation in the study e.g. history of thromboembolic disease or stroke.
  • Any medication the investigator considers may increase the risk of adverse effects during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191372

Locations
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Wing-Yen Wong, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01191372     History of Changes
Other Study ID Numbers: ARC19499-001, 2010-020373-17, 271101
Study First Received: August 26, 2010
Last Updated: April 5, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Baxter Healthcare Corporation:
Hemophilia A
Hemophilia B
pharmacokinetics
pharmacodynamics
Tissue Factor Pathway Inhibitor

Additional relevant MeSH terms:
Lipoprotein-associated coagulation inhibitor
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 29, 2014